Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.
**TOP 10 LIFE SCIENCES PODCAST**
Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?
Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?
Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?
There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.
I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.
Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:
- Master bioprocess development with confidence and clarity
- Excel at scale-up and manufacturing of biologics
- Transform your innovative therapy and manufacturing technology into market-ready solutions faster
- Optimize manufacturing costs without compromising quality
- Make data-driven decisions that reduce the risk of failure
I can’t wait to help you do biotech the smart way.
Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.
Ready to transform your biomanufacturing journey? Let's dive in!
Next Steps:
Book a free call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call
🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders
Accelerate biologics development with expert guidance: https://bruehlmann-consulting.com
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
180: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davis - Part 2
The promise of advanced cell therapies is undeniable, but as demand skyrockets, the challenges of taking a living drug from bench to bedside have never been greater. Each batch brings variability, each jurisdiction adds regulatory hurdles, and every strategic decision can determine whether a lifesaving therapy reaches patients or fizzles out behind clinical barriers.
Lindsay Davies is a leading figure in the cell and gene therapy field, serving as Vice President-Elect for Europe at the International Society of Cell and Gene Therapy (ISCT). She is Chief Scientific Officer at NextCell Pharma, co-founder of QVance, and founder of the consultancy CellTherEx. With over 20 years of experience across academia and industry, she brings deep expertise in MSC manufacturing, process development, and commercialization of advanced therapies. Here are three reasons this episode is a must-listen:
- Manufacturing at Scale, Without Compromise: Lindsay shares why NextCell Pharma has stuck with large-scale 2D manufacturing for MSCs, leveraging cell morphology and a patented donor selection algorithm to reduce batch-to-batch variability while maximizing reproducibility and safety, even when treating hundreds from a single batch.
- Smart Scaling: Up, Out, or Both? The debate isn’t just academic. Lindsay explores when it makes sense to scale up processes versus scaling out to multiple manufacturing sites. She highlights how harmonizing global regulatory expectations and moving to closed 2D systems can lower costs, de-risk production, and bring life-changing therapies to more patients worldwide.
- Network or Nowhere: Lindsay calls out the myth of the lone innovator, championing the crucial role of strategic networking, partnership models, including “sweat equity”, and early regulatory engagement as keys to avoiding the common commercialization pitfalls that stall so many promising ATMPs.
Wondering how to navigate the twin challenges of process control and commercial viability in ATMP development? This episode offers a rare, candid roadmap from the front lines.
Connect with Lindsay Davis:
LinkedIn: www.linkedin.com/in/lindsay-c-davies
Website: www.nextcellpharma.com
If you're interested in breakthroughs in cell therapy, here's what some of our previous guests have shared from the front lines of innovation:
- Episodes 105-106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer
- Episodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier Detournay
- Episodes 125-126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei
Next step:
Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call
🧬 Ready to eliminate CMC chaos and hit your IND timeline with absolute certainty? Get the complete Notion CMC Dashboard at https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders - the proven roadmap that's guided successful mAb programs to hit their IND submission deadlines.